Session: Medical Devices and Pharmaceuticals

Paper Number: 152947

152947 - Advancing Medical Device Compliance With Vvuq 

Abstract: 

In the evolving landscape of medical device development, ensuring safety, efficacy, and regulatory compliance is paramount. This paper unveils a novel approach to Verification, Validation, and Uncertainty Quantification (VVUQ) within the medical device lifecycle, powered by Siemens Xcelerator tools.

An innovative workflow is proposed which integrates Teamcenter as the central hub for data and process management, ensuring a coordinated and traceable VVUQ process. Teamcenter facilitates seamless simulation execution, while Amesim serves as the robust Verification and Validation (V&V) tool for system-level simulation, delivering unparalleled insights into device performance.

Siemens’ deep expertise in process and data management within highly regulated industries uniquely positions it to support medical device companies. As companies strive to incorporate Computer-Aided Engineering (CAE) simulations into their regulatory submissions, Siemens Xcelerator tools enable customers to do so with confidence. In this space, the VVUQ-40 journey begins with defining the context of use (COU) and assessing model risks, setting the stage for establishing credibility goals that steer the planning and execution of V&V activities. This dynamic process continuously evaluates model credibility for its specific COU, culminating in comprehensive documentation and evidence essential for regulatory submissions.

This methodology is essential for complex medical devices that depend on computational models for safety-critical functions. Furthermore, uncertainty quantification is crucial to ensure performance under diverse clinical conditions. By leveraging Siemens Xcelerator tools and incorporating risk-informed model credibility assessments, a holistic framework is presented for achieving compliance with global regulatory standards, including those set by the FDA.

In the evolving landscape of medical device development, ensuring safety, efficacy, and regulatory compliance is paramount. This paper unveils a novel approach to Verification, Validation, and Uncertainty Quantification (VVUQ) within the medical device lifecycle, powered by Siemens Xcelerator tools.

An innovative workflow is proposed which integrates Teamcenter as the central hub for data and process management, ensuring a coordinated and traceable VVUQ process. Teamcenter facilitates seamless simulation execution, while Amesim serves as the robust Verification and Validation (V&V) tool for system-level simulation, delivering unparalleled insights into device performance.

Siemens’ deep expertise in process and data management within highly regulated industries uniquely positions it to support medical device companies. As companies strive to incorporate Computer-Aided Engineering (CAE) simulations into their regulatory submissions, Siemens Xcelerator tools enable customers to do so with confidence. In this space, the VVUQ-40 journey begins with defining the context of use (COU) and assessing model risks, setting the stage for establishing credibility goals that steer the planning and execution of V&V activities. This dynamic process continuously evaluates model credibility for its specific COU, culminating in comprehensive documentation and evidence essential for regulatory submissions.

This methodology is essential for complex medical devices that depend on computational models for safety-critical functions. Furthermore, uncertainty quantification is crucial to ensure performance under diverse clinical conditions. By leveraging Siemens Xcelerator tools and incorporating risk-informed model credibility assessments, a holistic framework is presented for achieving compliance with global regulatory standards, including those set by the FDA.

Presenting Author: Mark Carlson Siemens

Presenting Author Biography: Accomplished Mechanical Engineering Analyst with 20+ years of experience in computer aided engineering. Implementing best modeling practice, improving solution efficiency and producing actionable results. Experience producing models within a vast array of industries, diverse and interacting physical phenomena and complex material properties. Effective in optimizing designs and understanding the impacts obtained from simulation results through design of experiments, data analysis and data visualization. Engineering project manager able to deliver high-confidence results, develop & implement methodological practices. Knowledgeable in user experience and programming practice for simulation customization and vertical applications. Innovative engineer recognized as the author of multiple engineering journal articles and technical papers. Holder of 2 patents.

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